Smartphone-assisted training with education for patients with hip and/or knee osteoarthritis (SmArt-E): study protocol for a multicentre pragmatic randomized controlled trial

Introduction Hip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care. Methods This study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation. Discussion After a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants’ behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs. Trial registration German Clinical Trials Register, DRKS00028477. Registered on August 10, 2022. Supplementary Information The online version contains supplementary material available at 10.1186/s12891-023-06255-7.

Throughout the intervention, participants have access to the app with controllable training programmes, educational modules and occasional video coaching sessions with their physiotherapists. The app should be used 1-2 times a week.
After the initial phase, the participants carry out the training independently at home with the support of the app. In addition, after six months, a "refresher" of one to three individual sessions of 40 minutes each takes place to support the continuation of the self-training. If you are interested in our study, we ask you to take part in three separate measurement dates within the next twelve months: at the beginning (t0), after three months (t1) and at the end of the study after one year (t2). To keep the effort for you low, you can attend the appointments at the study centre, or at a participating physiotherapy practice near you.
Here you will perform performance tests under the guidance of our trained staff and complete questionnaires. For these examinations we plan a duration of 2.5-3 hours in the first appointment. (t0) and up to 1.5 hours for the follow-up appointments (t1 und t2).
We would also like to ask you to wear an activity monitor (ActiGraph) to record your everyday activity for ten days after the above-mentioned measurement appointments. It is a small and lightweight monitor that is attached with a strap and and you can put it on and take it off yourself (dimensions: 3.8 x 3.7 1.8 cm, weight: 27 grams). The device measures accelerations ("activity counts"), which are then read out on a PC and translated into sedentary, moderate or strenuous physical activity using an algorithm. This data is only accessible to project staff and is stored using your study ID (pseudonymised).
As part of the study, personal data is collected and evaluated that is necessary to achieve the goals mentioned above. This includes:  self-reported socio-demographic and health-related data (e.g. age, gender, employment, information on health situation)  Data from the performance tests to describe the interaction of strength, mobility and coordination Routine data from your health insurance company from the twelve months before and the twelve months during the intervention. These contain information on costs, diagnoses, procedures and the scope of services (e.g. number of doctor visits, length of hospital stay). They cover the following service areas: outpatient medical services, inpatient and outpatient hospital care, rehabilitative measures, home care as well as medicines, remedies and aids. In addition to health economic effects, changes in the use of services due to the intervention should be recognized. Your name and date of birth will also be used to link with other data collected as part of the study. However, this information is only received by a trust agency and not by any person entrusted with the evaluations (Competence Center for Clinical Trials Bremen (KKSB), see data protection). This means that no conclusions can be drawn individually.
In addition, we would like to test the user-friendliness of the app with six people in the Bochum area. The participants will be given ten tasks to carry out in the app (e.g. "Navigate to the start screen") and to comment on (e.g. "What do you think about the clarity of this start page"). The duration of this test is about 15-20 minutes.
This method helps us to improve the user-friendliness of the app. You can revoke your participation in this at any time, even without giving reasons. In this case, you will not suffer any disadvantages and you do not have to withdraw from the study.

Process evaluation
In the course of "SmArt-E" you may be invited to participate in the process evaluation. In this case, we would be pleased if you accept the invitation and share your experiences with the